Cold Therapy for Pain Control Following Caesarean Section
2022年6月1日 更新者:University of Tennessee
Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital
Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections.
The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.
研究概览
详细说明
Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world.
In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010.
While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp).
This has lead to an increase in associated cost and problems with pain management.
Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost.
Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery.
CT has been used to improve range of motion (rom) and reduce pain medication utilization.
We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn.
This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF).
This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates.
The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT.
This will be done as a Randomized Controlled Trial (RCT).
研究类型
介入性
注册 (实际的)
2
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37403
- Erlanger Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 43年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- greater than 36 weeks gestation
- primary C/S with Epidural for labor problems or breech presentation
- Repeat C/S with spinal
Exclusion Criteria:
- less than 36.0 week gestations
- vertical skin incisions
- classical or vertical hysterotomy incisions
- failed vaginal births after C/S (VBAC)
- past history of drug or alcohol abuse
- positive drug screens unless medical prescribed drugs
- general anesthesia
- Caesarean Hysterectomy
- primary C/S with spinal anesthesia
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Repeat C/S Control
Repeat C/S done with spinal without Alkantis ice pack but with similar size dressings.
|
|
有源比较器:Repeat C/S Treatment
Repeat C/S done with spinal with Alkantis ice pack.
|
cold therapy pack placed on the wound post operatively
|
无干预:Primary C/S - Control
Primary C/S done with Epidural without Alkantis ice pack but with similar size dressings.
|
|
有源比较器:Primary C/S Treatment
Primary C/S done with Epidural with Alkantis ice pack.
|
cold therapy pack placed on the wound post operatively
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Post Operative Pain
大体时间:48 hours after surgery
|
Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.
|
48 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Narcotic Utilization
大体时间:48 hours after surgrey
|
Evaluate total narcotics used during time frame
|
48 hours after surgrey
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:William E Gist, M.D.、University of Tennessee College of Medicine- Chattanooga
- 研究主任:Kreg Jonson, M.D.、University of Tennessee College of Medicine- Chattanooga
- 研究主任:Mandi Raper、University of Tennessee College of Medicine- Chattanooga
- 研究主任:Erin Tannous, MD、University of Tennessee College of Medicine- Chattanooga
- 学习椅:Olkayoude Akinlaja, MD、University of Tennessee College of Medicine- Chattanooga
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
- Kullenberg B, Ylipaa S, Soderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9. doi: 10.1016/j.arth.2006.02.159.
- Placek PJ, Taffel SM. Trends in cesarean section rates for the United States, 1970--78. Public Health Rep. 1980 Nov-Dec;95(6):540-8.
- Placek PJ, Taffel S, Moien M. Cesarean section delivery rates: United States, 1981. Am J Public Health. 1983 Aug;73(8):861-2. doi: 10.2105/ajph.73.8.861.
- Stafford RS. Alternative strategies for controlling rising cesarean section rates. JAMA. 1990 Feb 2;263(5):683-7.
- Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992 Jul;167(1):108-9. doi: 10.1016/s0002-9378(11)91638-x.
- Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: prospective randomized study. Hernia. 2006 Apr;10(2):184-6. doi: 10.1007/s10029-005-0062-2. Epub 2006 Jan 24.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年12月1日
初级完成 (实际的)
2019年12月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2016年1月25日
首先提交符合 QC 标准的
2018年10月16日
首次发布 (实际的)
2018年10月19日
研究记录更新
最后更新发布 (实际的)
2022年6月2日
上次提交的符合 QC 标准的更新
2022年6月1日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
术后疼痛的临床试验
-
Kartos Therapeutics, Inc.招聘中原发性骨髓纤维化 (PMF) | 真性红细胞增多症后 MF (Post-PV-MF) | 原发性血小板增多症后 MF (Post-ET-MF)美国, 大韩民国, 德国, 澳大利亚, 匈牙利, 法国, 西班牙, 意大利, 台湾, 泰国, 巴西, 波兰, 火鸡, 以色列, 葡萄牙, 罗马尼亚, 阿根廷, 保加利亚, 加拿大, 克罗地亚, 捷克语, 立陶宛, 墨西哥, 菲律宾, 英国, 香港, 俄罗斯联邦, 希腊
-
Suzhou Zelgen Biopharmaceuticals Co.,Ltd完全的原发性骨髓纤维化 (PMF) | 真性红细胞增多症后骨髓纤维化(Post-PV MF) | 原发性血小板增多症后骨髓纤维化(Post-ET MF)中国